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Bordetella pertussis/parapertussis DNA, Qualitative, Real-Time PCR
Test Code11365
CPT Codes
87798 (x2)
Includes
Bordetella pertussis DNA and Bordetella parapertussis DNA
Preferred Specimen
1 mL nasopharyngeal aspirate collected in a sterile vial OR nasopharyngeal swab collected in a Liquid Amies collection tube
Minimum Volume
0.3 mL
Other Acceptable Specimens
Nasopharyngeal swab submitted in a V-C-M medium (green-cap) tube or equivalent UTM or multimicrobe
media (M4) • eSwabs (Liquid Amies)
Instructions
Nasopharyngeal aspirates: Instill 1-1.5 mL of nonbacteriostatic saline (pH 7.0) into one nostril. Flush a plastic catheter or tubing with 2-3 mL of saline. Insert the tubing into the nostril parallel to the palate. Aspirate nasopharyngeal secretions. Repeat this procedure for the other nostril. Combine aspirates into a sterile vial.
Nasopharyngeal swab: Collection kits using Amies liquid, M4, VCM/UTM are acceptable. Swab tips may be polyester, rayon, nylon flocked. Flexible shafts must be used for proper collection. Accuracy of the test depends on the collection of ciliated epithelial cells material. Half the distance from the nostril to the base of the ear could be used as estimation of the site of collection. Gently insert swab into the nostril. Keep the swab near the septum floor of the nose while gently pushing into the posterior nasopharynx. Rotate swab 2-3 times and hold in place for few seconds for optimal collection. Collection of both nostrils is recommended but not required.
Nasopharyngeal swab: Collection kits using Amies liquid, M4, VCM/UTM are acceptable. Swab tips may be polyester, rayon, nylon flocked. Flexible shafts must be used for proper collection. Accuracy of the test depends on the collection of ciliated epithelial cells material. Half the distance from the nostril to the base of the ear could be used as estimation of the site of collection. Gently insert swab into the nostril. Keep the swab near the septum floor of the nose while gently pushing into the posterior nasopharynx. Rotate swab 2-3 times and hold in place for few seconds for optimal collection. Collection of both nostrils is recommended but not required.
Transport Temperature
Refrigerated (cold packs)
Specimen Stability
Nasopharyngeal aspirate
Room temperature: 48 hours
Refrigerated: 8 days
Frozen: 30 days
Nasopharyngeal swab
Room temperature: 7 days
Refrigerated: 7 days
Frozen: 30 days
Room temperature: 48 hours
Refrigerated: 8 days
Frozen: 30 days
Nasopharyngeal swab
Room temperature: 7 days
Refrigerated: 7 days
Frozen: 30 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Collection tubes with Amies gel or charcoal containing media • Samples collected using cotton or calcium
alginate tipped swabs • Rigid shaft swabs
alginate tipped swabs • Rigid shaft swabs
Methodology
Real-Time Polymerase Chain Reaction (PCR)
This test detects but does not distinguish between B. Pertussis and B. Holmesii.
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
A.M. Sets up 7 days a week.
Clinical Significance
Bordetella pertussis is the cause of whooping cough that may occur in unimmunized individuals. B. parapertussis is a related organism that causes a similar, but milder, disease. Laboratory diagnosis may require both culture and serological confirmation, although culture is difficult.
